Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2
Emory University
Summary
The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks.
Description
Depression is a widespread disorder (lifetime prevalence \>20%). Current antidepressant medications are effective for many patients; however, more than 30% fail to respond. Of the patients that do respond to treatment, some continue to suffer with primary symptoms of depression like an inability to experience pleasure, called anhedonia. In this regard, one biological pathway that may contribute to symptoms of depression and particularly anhedonia is inflammation. The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression…
Eligibility
- Age range
- 25–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * a. willing and able to give written informed consent * b. men or women, 25-55 years of age * c. a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), current, as diagnosed by the Structured Clinical Interview for DSM-5 * d. score of \>10 on the Patient Health Questionnaire-9 (PHQ-9) or HAM-D score ≥18 * e. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine) * f. c-reactive protei…
Interventions
- DrugCarbidopa Levodopa
Patients will receive between one and three tablets per day of 150 mg L-DOPA (administered with 37.5 mg carbidopa) to achieve doses ranging from 150 to 450 mg/day.
- DrugPlacebo
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive between one and three placebo tablets per day matching the Carbidopa Levodopa tablet.
Location
- Emory University HospitalAtlanta, Georgia